Manufacturing Associate II (DP)

Amneal • Chicago, IL

3d • Onsite

About The Position

The Manufacturing Associate II is a regular, full-time, non-exempt position at Kashiv BioSciences, LLC, in Chicago, Illinois. The role supports the manufacture of biotechnology products for clinical and commercial human use. Work takes place in controlled and classified environments, including GMP clean rooms and laboratories, and requires aseptic techniques and, in some areas, complete aseptic gowning. The employee must follow company policies and procedures, FDA current Good Manufacturing Practices (cGMP), and other applicable government requirements.

The position involves preparing materials and solutions, operating and maintaining manufacturing equipment, participating in formulation, filtration, and aseptic filling, performing in-process testing, and completing accurate batch and cGMP documentation. The employee helps maintain clean-room conditions and supplies, reports nonconformances and events, and may assist with technology transfer and packaging as needed.

The position offers hourly compensation of $30.00–$35.00, overtime eligibility at time-and-a-half, shift differentials for applicable evening shifts, and a short-term incentive opportunity such as a bonus or performance-based award within the first 12 months. Eligible employees have access to a flexible benefits program, including health and insurance benefits and a significant 401(k) matching contribution.

Manufacturing shifts listed are Shift A, 6:00 a.m.–2:30 p.m.; Shift B, 9:00 a.m.–5:30 p.m. for the first 14 days; Shift C, 2:00 p.m.–10:30 p.m.; and Shift D, 10:00 p.m.–6:30 a.m. Overtime, holidays, and weekends are required based on process requirements.

Requirements

• An associate college degree or higher in Biology, Chemistry, Biotechnology, Pharmacy, or a related field is preferred, or an equivalent of 1–4 years of industry experience is required.
• Basic verbal and written English communication skills, including the ability to understand technical information, procedures, batch records, and other documents.
• Ability to operate complex systems and equipment according to cGMPs, SOPs, and safety guidelines with minimal supervision.
• Basic ability to identify problems and troubleshoot equipment and manufacturing processes.
• Ability to work independently within SOPs and prescribed guidelines or as a team member, and to follow detailed directions.
• Computer skills for working with systems such as POMS, LIMS, SAP, and NetSuite.
• Ability to use word-processing, spreadsheet, and data-management tools.
• Knowledge of GMP and safety requirements.
• Ability to produce neat, legible documentation in accordance with Good Manufacturing and Good Documentation Practices.
• Ability to move around the facility, stand for long periods, and perform occasional bending, squatting, kneeling, stooping, pushing, pulling, and reaching; frequent repetitive motions are required.
• Ability to lift at least 25 pounds; frequently move 25–50 pounds on carts and move 100–250 pounds with assistance.
• Willingness to work overtime, holidays, and weekends as required by process needs.

Nice To Haves

• Experience operating autoclaves and filling machines.
• Experience with aseptic techniques and clean-room manufacturing.
• Knowledge of biotechnology operations and equipment, including aseptic filtration systems, aseptic sampling, filter integrity testing, stirrer plates, floor scales, peristaltic pumps, and weighing scales.
• Excellent interpersonal skills.

Responsibilities

• Perform line inspection and line clearance in ISO 6, ISO 7, and ISO 8 areas.
• Weigh and dispense materials.
• Operate part washers, autoclaves, filters, mixing systems, syringe fillers, and non-viable particle counters.
• Calibrate and verify pH and conductivity meters and weighing scales.
• Standardize and operate peristaltic pumps and perform filter integrity tests.
• Participate in drug product formulation and filtration and in aseptic filling activities while maintaining appropriate aseptic-area behavior.
• Clean ISO 5 and ISO 6 areas according to SOPs.
• Maintain inventory of disinfectant solutions, gowns, goggles, wipes, and other supplies.
• Verify raw materials and other consumables.
• Assemble, clean, sterilize, and operate equipment.
• Prepare media and buffer solutions.
• Submit samples and perform in-process tests, including pH, conductivity, and personnel monitoring plates.
• Submit documents and material requests to the appropriate department to start batch manufacturing operations.
• Electronically record process steps when required.
• Complete batch records and other cGMP documentation accurately and promptly.
• Remove and dispose of soiled or expired materials from manufacturing areas.
• Maintain manufacturing areas within the conditions required for clean-room manufacturing.
• Report nonconformances and events occurring during the shift to the Supervisor.
• Assist with technology transfer from Process Development to cGMP Manufacturing.
• Perform packaging and other assigned functions as required.
• Comply with company safety, cGMP, and other policies, practices, procedures, and standards.

Benefits

• Short-term incentive opportunity, such as a bonus or performance-based award, within the first 12 months.
• Overtime eligibility with time-and-a-half pay.
• Shift differentials for applicable evening shifts.
• Flexible benefits program for eligible positions.
• Health and insurance benefits.
• Significant 401(k) matching contribution.
• Employee well-being programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree